AquaBounty Technologies, Inc. Announces FDA Approval of First U.S. Facility for Commercial Production of AquAdvantage Salmon
May 02 2018 - 9:21AM
AquaBounty Technologies, Inc. (Nasdaq:AQB) (“AquaBounty” or the
“Company”), a biotechnology company focused on enhancing
productivity in the aquaculture market and a majority-owned
subsidiary of Intrexon Corporation (NYSE:XON), today announces that
it has received approval from the U.S. Food and Drug Administration
(FDA) to raise AquAdvantage® Salmon at its land-based contained
facility near Albany, Indiana.
The FDA previously approved AquaBounty’s New Animal Drug
Application (NADA) on November 19, 2015, for the production, sale,
and consumption of AquAdvantage Salmon in the United States. That
approval specified that all production facilities for the product
would require separate site-specific approvals. To conform with
this requirement, the Company submitted a supplementary NADA to the
FDA requesting approval to grow AquAdvantage Salmon at its farm
site near Albany, Indiana. The Indiana facility as currently
configured has a production capacity of 1200 tons per year and was
designed to allow significant expansion. With the facility now
approved, commercial production of AquAdvantage Salmon awaits only
official labeling guidelines by the FDA.
AquaBounty CEO Ron Stotish stated, “This is another milestone in
our journey to bring our healthy and sustainable salmon to
consumers. We are very pleased the FDA has continued their rigorous
science-based review process and approved our application on its
merits. Our Albany facility is within a few hours' drive of major
markets in Indianapolis, Chicago, Detroit, Cleveland, Columbus,
Louisville, and St. Louis, providing us with tremendous opportunity
for growth. We still have work to do before we can start
production, but we take great pride in this latest
accomplishment.”
Shannon Henry, Delaware County Commissioner, added, “We are
extremely excited that a cutting-edge aquaculture company like
AquaBounty chose Delaware County to grow their operation. The jobs
being created at this facility and large capital investment is
welcomed news. We will continue to support their efforts.”
About AquAdvantage Salmon – AquAdvantage Salmon is an Atlantic
salmon that has been enhanced to grow to market size in about half
the time of a traditional farmed Atlantic salmon. It is grown only
in land-based contained facilities using a sterile, all-female
population. AquAdvantage Salmon is a healthy, environmentally
sustainable alternative to conventional farmed Atlantic salmon.
More information about AquaBounty is available at
www.aquabounty.com.
Forward-Looking Statements
This press release contains “forward-looking statements” as
defined in the Private Securities Litigation Reform Act of 1995, as
amended, that involve significant risks and uncertainties about
AquaBounty, including, but not limited to, statements with respect
to AquaBounty’s expectations for production and hiring at the
Albany facility and the timing thereof, the anticipated production
capacity and the potential for expansion at the Albany facility,
the impact of the Albany facility on the local economy, the
potential market for AquAdvantage Salmon and its impact on the
growth of the Company, and the prospects for removal of regulatory
restrictions on the importation of AquAdvantage Salmon into the
United States. AquaBounty may use words such as “expect,”
“anticipate,” “project,” “intend,” “plan,” “aim,” “believe,”
“seek,” “estimate,” “can,” “focus,” “will,” and “may” and similar
expressions to identify such forward-looking statements.
Forward-looking statements are not promises or guarantees of future
performance and are subject to a variety of risks and uncertainties
that could cause actual results to differ materially from those
contemplated in these forward-looking statements, including, but
not limited to, risks relating to whether or not AquaBounty will be
able to obtain additional funding; developments in or the outcome
of litigation challenging the FDA’s approval of AquAdvantage
Salmon; the introduction of additional statutory or regulatory
restrictions on the importation, production, or sale of
AquAdvantage Salmon in the United States; AquaBounty’s ability to
effect removal of all regulatory restrictions on such importation,
production, or sale; and the degree of consumer acceptance of
AquAdvantage Salmon. For additional disclosure regarding these and
other risks faced by AquaBounty, see disclosures contained in
AquaBounty’s public filings with the Securities and Exchange
Commission (“SEC”), including the “Risk Factors” in the company’s
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q,
available on the Investors section of AquaBounty’s website at
www.aquabounty.com and on the SEC’s website at www.sec.gov. You
should consider these factors in evaluating the forward-looking
statements included in this press release and not place undue
reliance on such statements. The forward-looking statements are
made as of the date hereof, and AquaBounty undertakes no obligation
to update such statements as a result of new information.
Contact
AquaBounty Technologies, Inc.
Dave Conley, Director of Communications
+1 613 294 3078
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